UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
On March 3, 2022, the Patented Medicine Prices Review Board (the “PMPRB” or the “Board”) released its 2022-23 Departmental Plan [PDF] outlining its priorities and planned use of resources for the coming year, with an emphasis on managing the new price control regime ushered in by the 2019 amendments to the Patented Medicines Regulations (the “Amendments”). The Amendments and accompanying PMPRB Guidelines are expected to come into force on July 1, 2022.
The Departmental Plan comes in the wake of successful legal challenges relating to the PMPRB, including February’s Quebec Court of Appeal decision partially invalidating the Amendments. More recently, the Supreme Court of Canada dismissed the Attorney General’s application for leave to appeal the decision in Alexion Pharmaceuticals Inc v Canada (Attorney General) (2021 FCA 157), in which the Federal Court of Appeal defined the PMPRB’s mandate as “preventing abusive pricing,” and contrasted this with the improper purposes of “price control” and ensuring “reasonable pricing.”
Highlights from the PMPRB’s 2022-23 Departmental Plan
Goals for 2022-2023: The PMPRB considers itself to be in a holding pattern due to the delays in the rollout of the new regime. As such, the two stated priorities for the coming year are the same as they were in the 2021-22 Departmental Plan: (1) to implement the new pricing framework and begin evaluating its impact; and (2) to support the federal government’s high-level priorities for the future of pharmaceutical management in Canada.
Timing of Amendments: The PMPRB is not ruling out the possibility of further postponements brought on by the COVID-19 pandemic, and notes that the timing is out of its hands as it is a decision made by the Minister of Health and the Governor in Council.
GMEP: The PMPRB plans to finalize the Guidelines Monitoring and Evaluation Plan (the “GMEP”) that was the subject of a consultation in the summer of 2021.
The purpose of the GMEP is to analyze trends in the pharmaceutical market, particularly regarding prices, access, the pharmaceutical ecosystem and PMPRB processes.
Compliance: The PMPRB sees a risk that voluntary compliance with the Guidelines may decline as patentees test the boundaries of the new regime. The Board believes it has enough resources to contend with an increase in the number of investigations and hearings into the prices of patented medicines.
Mandate: The PMPRB expects to be called upon to support several new federal government priorities, including the potential establishment of a Canadian Drug Agency, a national formulary, and a rare disease drug strategy. The Board has not yet signaled an intention to be involved in the national pharmacare program that was announced recently, but we will be watching to see if this becomes part of its mandate.
